KARL STORZ ENDOSCOPY CANADA LTD.

FDA Device Registration & Listing · Mississauga Ontario, CA · Registration 3012322232

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012322232
FEI Number
3012322232
Entity Name
KARL STORZ ENDOSCOPY CANADA LTD.
City/State/Country
Mississauga Ontario, CA
Establishment Address
7171 Millcreek Drive, Mississauga Ontario L5N 3R3, CA
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
KARL STORZ Endoscopy Canada Ltd. (Owner Number: 10084187)
Owner / Operator Contact Address
7171 Millcreek Drive, Mississauga, CA-ON L5N 3R3, CA
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K945211
PMA Number
N/A

All Registered Proprietary Names

KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG KARL STORZ SE & CO. KG

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MKT Hepatitis Viral B Dna Detection Microbiology Class 2 866.3174 2024-12-10
KQM Camera, Surgical And Accessories General, Plastic Surgery Class 1 878.4160 2024-12-10
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2024-12-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-10
MRK System, Imaging, Fluorescence Unknown Class 3 N/A 2024-12-10
FGC Urethroscope Gastroenterology, Urology Class 2 876.1500 2024-12-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-10
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2024-12-10
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 2024-12-10
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2024-12-10
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2022-01-27
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-12-10
NTN Led Light Source Gastroenterology, Urology Class 2 876.1500 2024-12-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-10
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 2022-01-27
FHQ Holder, Needle, Gastroenterologic Gastroenterology, Urology Class 1 876.4730 2022-01-24
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-10
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 2022-01-27
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2024-12-10
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2024-12-10
FCW Light Source, Fiberoptic, Routine Gastroenterology, Urology Class 2 876.1500 2024-12-10
GCT Light Source, Endoscope, Xenon Arc Gastroenterology, Urology Class 2 876.1500 2024-12-10
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-12-10
HFA Amnioscope, Transabdominal (Fetoscope) (And Accessories) Obstetrics/Gynecology Class f 884.1600 2024-12-10
GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered General Hospital Class 2 880.6740 2024-12-10
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-12-10
OCX Endoscopic Irrigation/Suction System Gastroenterology, Urology Class 2 876.1500 2024-12-10
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2024-12-10
BTA Pump, Portable, Aspiration (Manual Or Powered) General, Plastic Surgery Class 2 878.4780 2024-12-10
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2024-12-10
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-12-10
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-10
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2024-12-10
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2024-12-10
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope Gastroenterology, Urology Class 2 876.1500 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-12-10
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
HCY Curette, Uterine Obstetrics/Gynecology Class 1 884.4530 2022-01-27
FWF Camera, Television, Endoscopic, Without Audio General, Plastic Surgery Class 1 878.4160 2022-01-24
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-10
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-12-10
FDZ Attachment, Eyepiece, For Insertion Of Prescription Lens Gastroenterology, Urology Class 1 876.1500 2022-01-27
EOX Esophagoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4710 2024-12-10
EPT Microscope, Surgical General, Plastic Surgery Class 1 878.4700 2024-12-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-10
NBH Accessories, Arthroscopic Orthopedic Class 1 888.1100 2024-12-10
KNY Accessories, Catheter, G-U Gastroenterology, Urology Class 2 876.5130 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
EWQ Saw, Surgical, Ent (Electric Or Pneumatic) Ear, Nose, Throat Class 1 874.4420 2022-01-27
KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) Obstetrics/Gynecology Class 2 884.4160 2024-12-10
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-12-10
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
JOS Electrode, Electrosurgical General, Plastic Surgery Class 2 878.4400 2024-12-10
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-12-10
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-12-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-12-10
FBO Cystourethroscope Gastroenterology, Urology Class 2 876.1500 2024-12-10
HIG Insufflator, Hysteroscopic Obstetrics/Gynecology Class 2 884.1700 2024-12-10
EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4760 2024-12-10
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-12-10
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-10
MDM Instrument, Manual, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2024-12-10
OWN Confocal Optical Imaging Gastroenterology, Urology Class 2 876.1500 2024-12-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-10
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-12-10
FDC Resectoscope, Working Element Gastroenterology, Urology Class 2 876.1500 2024-12-10
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2024-12-10
FAS Electrode, Electrosurgical, Active, Urological Gastroenterology, Urology Class 2 876.4300 2024-12-10
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2024-12-10
HIH Hysteroscope (And Accessories) Obstetrics/Gynecology Class 2 884.1690 2024-12-10
GWG Endoscope, Neurological Neurology Class 2 882.1480 2024-12-10
KCD Bougie, Esophageal, Ent Ear, Nose, Throat Class 1 874.4420 2022-01-27
EWY Mediastinoscope, Surgical Ear, Nose, Throat Class 2 874.4720 2024-12-10
FJL Resectoscope Gastroenterology, Urology Class 2 876.1500 2024-12-10
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-10
FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology Gastroenterology, Urology Class 2 876.1500 2024-12-10
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered Gastroenterology, Urology Class 2 876.1500 2024-12-10
FCL Forceps, Biopsy, Non-Electric Gastroenterology, Urology Class 1 876.1075 2024-12-10
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2024-12-10
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-10
HET Laparoscope, Gynecologic (And Accessories) Obstetrics/Gynecology Class 2 884.1720 2024-12-10

Official Correspondent

Diana Faddoul

US Agent Details

Anja Fair Business: KARL STORZ ENDOSCOPY-AMERICA, INC. Email: anja.fair@karlstorz.com Phone: (346) 8168200

Related Public Records

Same Entity

KARL STORZ Endoscopy Canada Ltd.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K961841 C.R. Bard, Inc. BARD V-MAX ROLLER BAR (3551XX;XX=01,02,03,04,05, OR 06) 1996-10-09
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0144-2024 Covidien 1
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012322232. Last updated year: 2026. Please use registration number 3012322232 when referencing this establishment in official correspondence.
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